Study of Rivoglitazone in Type 2 Diabetes Mellitus

July 6, 2021 updated by: Daiichi Sankyo, Inc.

A Randomized, Double-blind, Placebo and Active Comparator-Controlled, Parallel-Group Study of the Efficacy and Safety of Rivoglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus

This is a 26-week study in subjects with type 2 diabetes currently sub-optimally controlled by diet and exercise or with non-thiazolidinedione antihyperglycemic monotherapy. The total duration of a subject's participation will be approximately 30 weeks, including a 2-week placebo run-in period, a 26-week double-blind treatment period, and a 2-week post-treatment follow-up period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1912

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Buenos Aires
      • Loma Verde, Buenos Aires, Argentina
      • Zarate, Buenos Aires, Argentina
    • Cordoba
      • San Vicente, Cordoba, Argentina
  • Austria
      • Feldkirch, Austria
      • Graz, Austria
      • Wien, Austria
  • Chile
      • Santiago, Chile
      • Temuco, Chile
    • Providencia
      • Santiago, Providencia, Chile
  • Czechia
      • Horní Město, Czechia
      • Karlovy Vary, Czechia
      • Prague, Czechia
      • Praha, Czechia
      • Usti nad Labem, Czechia
      • Vysoký Les, Czechia
      • Zlin, Czechia
      • Znojmo, Czechia
  • Germany
      • Aschaffenburg, Germany
      • Augsburg, Germany
      • Bad Oeynhausen, Germany
      • Berlin, Germany
      • Bosenheim, Germany
      • Dortmund, Germany
      • Dresden, Germany
      • Friedrichsthal, Germany
      • Giessen, Germany
      • Halle, Germany
      • Hamburg, Germany
      • Kippenheim, Germany
      • Mainz, Germany
      • Rehlingen, Germany
      • Riesa, Germany
      • Saarbrucken, Germany
      • Saarlouis, Germany
      • Siegen, Germany
      • Wiesbaden, Germany
  • Hungary
      • Balatonfured, Hungary
      • Bekescsaba, Hungary
      • Budapest, Hungary
      • Debrecen, Hungary
      • Eger, Hungary
      • Gyula, Hungary
      • Kaposvar, Hungary
      • Szentes, Hungary
  • India
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India
      • Vijayawada, Andhra Pradesh, India
      • Visakhapatnam, Andhra Pradesh, India
    • Bangalore
      • Vasanth Nagar, Bangalore, India
    • Chennai
      • Mylapore, Chennai, India
    • Ghaziabad
      • Shastri Nagar, Ghaziabad, India
    • Gujarat
      • Ahmedabad, Gujarat, India
      • Gandhinagar, Gujarat, India
    • Haryana
      • Karnal, Haryana, India
    • Jaipur
      • Sarwa C., Jaipur, India
    • Karnataka
      • Bangalore, Karnataka, India
      • Belgaum, Karnataka, India
      • Mangalore, Karnataka, India
    • Kerala
      • Kochi, Kerala, India
    • Madhya Pradesh
      • Indore, Madhya Pradesh, India
    • Maharashtra
      • Mumbai, Maharashtra, India
    • Nagpur
      • Dhantoli, Nagpur, India
      • Ramdaspeth, Nagpur, India
    • Rajasthan
      • Jaipur, Rajasthan, India
    • Tamil Nadu
      • Coimbatore, Tamil Nadu, India
    • Uttar Pradesh
      • Aligarh, Uttar Pradesh, India
  • Latvia
      • Daugavpils, Latvia
      • Kuldiga, Latvia
      • Liepaja, Latvia
      • Riga, Latvia
  • Mexico
      • Aguascalientes, Mexico
      • Durango, Mexico
      • Puebla, Mexico
    • Morelos
      • Cuernavaca, Morelos, Mexico
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico
    • Toluca
      • Metepec, Toluca, Mexico
    • Yucatan
      • Merida, Yucatan, Mexico
  • Peru
      • Lima, Peru
    • Lima
      • La Victoria, Lima, Peru
      • Magdalena del Mar, Lima, Peru
      • San Juan de Miraflores, Lima, Peru
      • San Martin de Porres, Lima, Peru
    • Sucro Lima
      • Monterrico, Sucro Lima, Peru
  • Puerto Rico
      • Rio Piedras, Puerto Rico
      • San Juan, Puerto Rico
      • Villa Fontana, Puerto Rico, 00983
  • Romania
      • Arad, Romania
      • Brasov, Romania
      • Bucharest, Romania
      • Satu Mare, Romania
      • Targu Mures, Romania
  • Serbia
      • Belgrade, Serbia
      • Kragujevac, Serbia
      • Nis, Serbia
      • Subotica, Serbia
      • Zemun, Serbia
  • Slovakia
      • Bratislava, Slovakia
      • Lucenec, Slovakia
      • Moldava nad Bodvou, Slovakia
      • Nove Mesto nad Vahom, Slovakia
      • Považská Bystrica, Slovakia
      • Zilina, Slovakia
  • South Africa
      • Johannesburg, South Africa
      • Port Elizabeth, South Africa
  • Ukraine
      • Dnipropetrovs'k, Ukraine
      • Kharkov, Ukraine
      • Kiev, Ukraine
      • Lviv, Ukraine
      • Simferopol, Ukraine
  • United Kingdom
      • Chippenham, United Kingdom
    • London
      • Edmonton, London, United Kingdom
    • Middlesex
      • Sunbury, Middlesex, United Kingdom
    • Surrey
      • Addlestone, Surrey, United Kingdom
    • West Yorks
      • Wakefield, West Yorks, United Kingdom
    • Wiltshire
      • Swindon, Wiltshire, United Kingdom
  • United States
    • Alabama
      • Anniston, Alabama, United States
      • Birmingham, Alabama, United States
      • Hoover, Alabama, United States
      • Muscle Shoals, Alabama, United States
    • Arkansas
      • Hot Springs, Arkansas, United States
      • Jonesboro, Arkansas, United States
      • Little Rock, Arkansas, United States
    • California
      • Buena Park, California, United States
      • Garden Grove, California, United States
      • Huntington Park, California, United States
      • Los Angeles, California, United States
      • Paramount, California, United States
      • Sacramento, California, United States
      • San Diego, California, United States
      • Walnut Creek, California, United States
      • West Covina, California, United States
      • West Hills, California, United States
    • Colorado
      • Denver, Colorado, United States
    • Florida
      • Delray Beach, Florida, United States
      • Jacksonville, Florida, United States
      • Merritt Island, Florida, United States
      • Miami, Florida, United States
      • Pembroke Pines, Florida, United States
      • Tampa, Florida, United States
    • Hawaii
      • Honolulu, Hawaii, United States
    • Idaho
      • Boise, Idaho, United States
    • Illinois
      • Chicago, Illinois, United States
    • Indiana
      • Evansville, Indiana, United States
      • Indianapolis, Indiana, United States
    • Kansas
      • Wichita, Kansas, United States
    • Kentucky
      • Madisonville, Kentucky, United States
    • Louisiana
      • New Orleans, Louisiana, United States
      • Slidell, Louisiana, United States
    • Massachusetts
      • Springfield, Massachusetts, United States
    • Michigan
      • Portage, Michigan, United States
      • Southfield, Michigan, United States
    • Missouri
      • Saint Louis, Missouri, United States
    • New Jersey
      • Voorhees, New Jersey, United States
    • New York
      • Syracuse, New York, United States
    • North Carolina
      • Morehead City, North Carolina, United States
      • Salisbury, North Carolina, United States
      • Statesville, North Carolina, United States
      • Winston-Salem, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • Cleveland, Ohio, United States
      • Delaware, Ohio, United States
      • Lyndhurst, Ohio, United States
      • Marion, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
      • Tulsa, Oklahoma, United States
    • Oregon
      • Portland, Oregon, United States
    • Pennsylvania
      • Beaver, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
    • South Carolina
      • Charleston, South Carolina, United States
      • Columbia, South Carolina, United States
    • Tennessee
      • Cleveland, Tennessee, United States
      • Kingsport, Tennessee, United States
      • New Tazewell, Tennessee, United States
    • Texas
      • Carrollton, Texas, United States
      • Conroe, Texas, United States
      • Corpus Christi, Texas, United States
      • Dallas, Texas, United States
      • El Paso, Texas, United States
      • Garland, Texas, United States
      • Irving, Texas, United States
      • Midland, Texas, United States
      • San Antonio, Texas, United States
    • Virginia
      • Richmond, Virginia, United States
    • Washington
      • Olympia, Washington, United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of type 2 diabetes
  • Male or female at least 18 years of age
  • Hemoglobin A1C > 7% and less or equal to 8.5%
  • Non-fasting C-peptide > 0.5 ng/mL
  • Current monotherapy treatment with stable dose of approved non-Thiazolidinedione (TZD) antihyperglycemic medication for greater or equal to 3 months prior to screening or
  • Untreated with any antihyperglycemic agent during 2 months prior to screening

Exclusion Criteria:

  • History of type 1 diabetes or ketoacidosis
  • History of long-term therapy with insulin
  • Body Mass Index (BMI) > 45 kg/m^2
  • Known history of Congestive Heart Failure (CHF)
  • Impaired hepatic function
  • History of prior treatment failure with, or intolerance of, a TZD
  • Contraindication to treatment with pioglitazone
  • Treatment with fibrates
  • If untreated with oral antihyperglycemic, considered to have failed diet and exercise modification as the sole treatment for type 2 diabetes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 1
Drug: Placebo
Rivoglitazone-matching placebo administered as a tablet orally, once daily or a pioglitazone-matching placebo administered as an over-encapsulated tablet orally, once daily capsule
EXPERIMENTAL: 2
Rivoglitazone 1.0 mg
Drug: Rivoglitazone
1.0 mg tablet administered orally, once daily
Drug: Rivoglitazone
1.5 mg tablet administered orally, once daily
EXPERIMENTAL: 3
Rivoglitazone 1.5 mg
Drug: Rivoglitazone
1.0 mg tablet administered orally, once daily
Drug: Rivoglitazone
1.5 mg tablet administered orally, once daily
ACTIVE_COMPARATOR: 4
Pioglitazone 45 mg
Drug: Pioglitazone
45 mg over-encapsulated tablet administered orally, once daily
Other Names:
  • Actos

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin A1c at Baseline and Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Time Frame: Baseline up to week 26 post-dose
Percentage of hemoglobin A1c (HbA1c) levels are reported.
Baseline up to week 26 post-dose
Change in Hemoglobin A1c From Baseline Through Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Time Frame: Baseline up to 26 weeks post-dose
Percent change in hemoglobin (HbA1c) levels are reported. Greater (negative) percent change indicates improvement.
Baseline up to 26 weeks post-dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fasting Plasma Glucose From Baseline Through Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Time Frame: Baseline up to week 26 post-dose
Normal fasting plasma glucose (FPG) levels are being reported. Normal FPG levels range from 70-110 mg/dL. Lower FPG values indicates better clinical outcome, ie. improvement in FPG.
Baseline up to week 26 post-dose
Change in Fasting Plasma Glucose From Baseline Through Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Time Frame: Baseline up to 26 weeks post-dose
The change in normal fasting plasma glucose (FPG) levels are being reported. A greater (negative) change from baseline indicates an improvement in FPG.
Baseline up to 26 weeks post-dose
Homeostasis Model Assessment Index for Insulin Resistance At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Time Frame: Baseline up to week 26 post-dose

Homeostasis Model Assessment index for Insulin Resistance (HOMA-IR) was calculated as:

(fasting insulin concentration [μU/mL] x fasting glucose concentration [mmol/L])/22.5 Low HOMA-IR scores indicate high insulin sensitivity, whereas high HOMA-IR scores indicate low insulin sensitivity (insulin resistance). A normal HOMA-IR score is <2.60, HOMA-IR scores 2.60-3.80 are considered "borderline high", and HOMA-IR scores >3.80 are considered "high" and have correlations of insulin resistance. High HOMA-IR scores indicate worse outcome.
Baseline up to week 26 post-dose
Change in Homeostasis Model Assessment Index for Insulin Resistance At Baseline To Week 26 Endpoint With Last Observation Carried Forward Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Time Frame: Baseline up to 26 weeks post-dose

The change in the Homeostasis Model Assessment index for Insulin Resistance (HOMA-IR) was calculated as:

(fasting insulin concentration [μU/mL] x fasting glucose concentration [mmol/L])/22.5 Low HOMA-IR scores indicate high insulin sensitivity, whereas high HOMA-IR scores indicate low insulin sensitivity (insulin resistance). A normal HOMA-IR score is <2.60, HOMA-IR scores 2.60-3.80 are considered "borderline high", and HOMA-IR scores >3.80 are considered "high" and have correlations of insulin resistance. A negative HOMA-IR score indicates an improvement in insulin sensitivity.
Baseline up to 26 weeks post-dose
Total Cholesterol At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Time Frame: Baseline up to week 26 post-dose
Total cholesterol is a measure of the total amount of cholesterol in the blood, including low-density lipoprotein cholesterol (LDL-C) - the "bad" cholesterol, high-density lipoprotein cholesterol (HDL-C) - the "good" cholesterol, and triglycerides. The equation to calculate total cholesterol is: LDL + HDL + (triglycerides/5) = total cholesterol.
Baseline up to week 26 post-dose
Percent Change in Total Cholesterol From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Time Frame: Baseline up to 26 weeks post-dose
Total cholesterol is a measure of the total amount of cholesterol in the blood, including low-density lipoprotein cholesterol (LDL-C) - the "bad" cholesterol, high-density lipoprotein cholesterol (HDL-C) - the "good" cholesterol, and triglycerides. The equation to calculate total cholesterol is: LDL + HDL + (triglycerides/5) = total cholesterol. Higher percent change in total cholesterol indicates better outcome, ie. improvement.
Baseline up to 26 weeks post-dose
Total Triglycerides At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Time Frame: Baseline up to Week 26 post-dose
Total Triglycerides (TG) is a measure of the total amount of triglycerides in the blood. The equation to calculate total triglycerides is: (total cholesterol-Low-density Lipoprotein cholesterol (LDL- C) - High-density lipoprotein cholesterol (HDL- C)) x 5 = Total Triglycerides. Normal triglyceride levels are below 150 mg/dL.
Baseline up to Week 26 post-dose
Percent Change in Total Triglycerides From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Time Frame: Baseline up to 26 weeks post-dose
Total Triglycerides (TG) is a measure of the total amount of triglycerides in the blood. The equation to calculate total triglycerides is: (total cholesterol-Low-density Lipoprotein cholesterol (LDL- C) - High-density lipoprotein cholesterol (HDL- C)) x 5 = Total Triglycerides. A negative change means better outcome, ie. improvement.
Baseline up to 26 weeks post-dose
Low-Density Lipoprotein Cholesterol At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Time Frame: Baseline up to Week 26 post-dose
Low-density lipoprotein cholesterol (LDL-C), "bad" cholesterol, is a measure of the total amount of low-density lipoprotein cholesterol in the blood. Normal LDL levels are <100 mg/dL.
Baseline up to Week 26 post-dose
Percent Change in Low-Density Lipoprotein Cholesterol From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Time Frame: Baseline up to 26 weeks post-dose
Low-density lipoprotein cholesterol (LDL-C), "bad" cholesterol, is a measure of the total amount of low-density lipoprotein cholesterol in the blood. A higher percent change indicates improvement.
Baseline up to 26 weeks post-dose
High-Density Lipoprotein Cholesterol At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Time Frame: Baseline to Week 26 post-dose
High-density lipoprotein cholesterol (HDL-C), "good" cholesterol, is a measure of the total amount of high-density lipoprotein cholesterol in the blood. Normal HDL levels are >40 mg/dL.
Baseline to Week 26 post-dose
Percent Change in High-Density Lipoprotein Cholesterol From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Time Frame: Baseline to 26 weeks post-dose
High-density lipoprotein cholesterol (HDL-C), "good" cholesterol, is a measure of the total amount of high-density lipoprotein cholesterol in the blood. A higher percent change indicates improvement.
Baseline to 26 weeks post-dose
Apolipoprotein A-I At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Time Frame: Baseline to Week 26 post-dose
Apolipoprotein (Apo) A-I levels, a measure of the total amount of Apolipoprotein (Apo) A-I in the blood, are being reported. Normal Apo A-1 levels range from 120-140 mg/dL.
Baseline to Week 26 post-dose
Percent Change in Apolipoprotein A-I From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Time Frame: Baseline up to 26 weeks post-dose
Apolipoprotein (Apo) A-I is a measure of the total amount of Apolipoprotein (Apo) A-I in the blood. Decreased ApoA-1 levels are associated with poor clinical outcome. A lower percent change in ApoA-1 levels indicates an improvement in clinical outcome.
Baseline up to 26 weeks post-dose
Apolipoprotein B At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Time Frame: Baseline to Week 26 post-dose
Apolipoprotein (Apo) B, a measure of the total amount of Apo B in the blood, is being reported. Normal Apo B levels are <100 mg/dL.
Baseline to Week 26 post-dose
Percent Change in Apolipoprotein B From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Time Frame: Baseline up to 26 weeks post-dose
Apolipoprotein (Apo) B, a measure of the total amount of Apo B in the blood, is being reported. A greater (negative) percent change in ApoB levels indicated an improvement in clinical outcome.
Baseline up to 26 weeks post-dose
Hemoglobin A1c at Baseline and Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Time Frame: Baseline up to Week 52 post-dose
Percentage of hemoglobin A1c (HbA1c) levels are reported.
Baseline up to Week 52 post-dose
Change in Hemoglobin A1c From Baseline Through Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Time Frame: Baseline up to 52 weeks post-dose
Change in hemoglobin (HbA1c) levels are reported. Greater (negative) percent change indicates improvement.
Baseline up to 52 weeks post-dose
Fasting Plasma Glucose From Baseline Through Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Time Frame: Baseline up to Week 52 post-dose
Normal fasting plasma glucose (FPG) levels are being reported. Normal FPG levels range from 70-110 mg/dL. Lower FPG values indicates better clinical outcome, ie. improvement in FPG.
Baseline up to Week 52 post-dose
Change in Fasting Plasma Glucose From Baseline Through Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Time Frame: Baseline up to 52 weeks post-dose
The change in normal fasting plasma glucose (FPG) levels are being reported. A greater (negative) change from baseline indicates an improvement in FPG.
Baseline up to 52 weeks post-dose
Drug-Related Treatment-Emergent Adverse Events Reported by ≥1% Participants Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus
Time Frame: Week -2 up to Week 52 post-dose
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of double-blind study medication, and ongoing AEs that started prior to the first dose of double-blind study medication and increased in severity on or after the first dose of double-blind study medication.
Week -2 up to Week 52 post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daiichi Sankyo, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 23, 2007

Primary Completion (ACTUAL)

February 12, 2009

Study Completion (ACTUAL)

February 12, 2009

Study Registration Dates

First Submitted

June 7, 2007

First Submitted That Met QC Criteria

June 7, 2007

First Posted (ESTIMATE)

June 8, 2007

Study Record Updates

Last Update Posted (ACTUAL)

July 27, 2021

Last Update Submitted That Met QC Criteria

July 6, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS0011-A-U301
  • 2006-005047-28 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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